Outsourced API Manufacture

RML Pharma Consulting has extensive operational experience managing outsourced API manufacture globally at both low-cost and EU/US contract API manufacturers - ranging from gram through to multi-kg quantities.
 

  • Outsourced API Manufacture of API to non-GMP for early phase preclinical/investigative studies can be accommodated. API destined for all clinical trials will be manufactured to cGMP and as such, all activities will be performed to the appropriate quality standards to support any regulatory submissions.

      • RML Pharma Consulting use high quality contractors for all API manufacture. These contractors are based in UK/Europe, US and India and have been selected based on a combination of their technical competencies and equipment/volume capabilites and have delivered successfully on a large number of projects during the last 12 years.

          • We can also coordinate the outsourced manufacture of highly potent API (eg cytotoxics or highly active compounds) within our network of contractors.
            • RML Pharma Consulting have a strong relationship with our contract manufacturers, based on mutual trust and respect and as such we regard them as a pivotal part of any project team - by working very closely with them, we are able to identify potential issues early before they have an opportunity to escalate. This will benefit all of our customers.